FDA Cites Quality Problems at NY Brain-Imaging Lab

By: DAVID B. CARUSO, AP Email
By: DAVID B. CARUSO, AP Email

NEW YORK (AP) - A respected brain-imaging center run by Columbia
University has halted some research after federal officials repeatedly complained about the quality of drugs being used on patients.

The Food and Drug Administration found in a series of inspections that the center had failed to correct manufacturing problems in a lab that makes experimental drugs injected into psychiatric patients to help capture images of brain activity.

In one warning letter, an FDA office in New York described problems dating back to at least 2004. It cited a litany of violations, including a failure to reject batches of medication that didn't pass required purity tests. The drugs were for patients undergoing a type of brain scan called positron emission tomography.

"We are concerned about the quality control systems and procedural problems that have allowed these significant deficiencies to occur," the FDA told the center in the letter, written in December 2008.

In a statement sent Saturday to the Associated Press, Columbia University Medical Center said it was restructuring the laboratory that produces the drugs for the Kreitchman PET Center.

It said an internal investigation, performed at the FDA's request, had found "no evidence of patient harm," but that all activities relying on the manufactured compounds had been suspended while reforms were undertaken.

"We acknowledge serious shortcomings of quality control in the manufacturing process and record keeping at this lab," said Dr. David Hirsh, the medical center's executive vice president for research.

"That is why we are fundamentally reorganizing the lab's management and operations in response to what the FDA told us. When manufacturing resumes under new leadership, it will meet the strictest standards and best practices for ensuring the quality of these materials," Hirsh said.

The problems at the imaging center and the halt in research were first reported late Friday by The New York Times.

The PET Center remains in operation during the shake up, andpatients continue to receive treatment, Columbia said.

The problems at the center involved radioligands, which are pharmaceuticals injected into a patient's brain to assist in capturing images.

The drugs are not supposed to have any effect on the patient and they degrade quickly - so fast, in fact, that imaging centers must often manufacture them on the spot, rather than buy them from outside vendors.

The manufacturing process is strictly regulated by the FDA.


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